RU2016116915A

RU2016116915A - COMBINATION

Info

Publication number: RU2016116915A
Application number: RU2016116915A
Authority: RU
Inventors: Марк Дж. КОРНФЕЛЬД; Ракеш Кумар; Шэннон Рене Моррис
Original assignee: Новартис Аг
Priority date: 2013-10-01
Filing date: 2014-10-01
Publication date: 2017-11-13
Also published as: BR112016006976A2; EP3718544A1; AU2014330779A1; CN105792825A; WO2015049649A1; CA2925374A1; JP7235807B2; US20160228456A1; JP2021155446A; KR20160065910A; EP4265300A2; US20200222431A1; JP2016531884A; AU2017228673A1; US20170239274A1; CN109806266A; JP6907273B2; JP2019218357A; US20250017947A1; EP4265300A3

Claims

1. The combination, including:

(i) a compound of structure (I)

or a pharmaceutically acceptable salt or ester thereof;

and

(ii) a compound of structure (II)

or a pharmaceutically acceptable salt thereof.

2. The combination of claim 1, wherein compound (I) is in the form of an ester.

3. The combination of claim 1, wherein compound (I) is in the form of an acetate ester.

4. The combination according to claim 1, wherein compound (II) is in the form of a hydrochloride.

5. A combination kit comprising the combination of claim 1 or 2 together with a pharmaceutically acceptable carrier or carriers.

6. The use of a combination according to claim 1 or 2 for the manufacture of a medicament for the treatment of cancer.

7. The combination according to claim 1 or 2 for use in therapy.

8. The combination of claim 1 or 2 for use in the treatment of cancer.

9. A pharmaceutical composition comprising a combination of claim 1 or 2 together with a pharmaceutically acceptable diluent or carrier.

10. A method of treating cancer in a person in need thereof, which comprises administering a therapeutically effective amount

(i) compounds of structure (I)

or a pharmaceutically acceptable salt or ester thereof;

and

(ii) compounds of structure (II)

or a pharmaceutically acceptable salt thereof for use in therapy.

11. The method of claim 10, wherein the cancer is selected from head and neck cancer, breast cancer, lung cancer, colon cancer, ovarian cancer, prostate cancer, glioma, glioblastoma, astrocytoma, multiple glioblastoma, Banyan-Zonan syndrome, disease Cowden, Lermit-Duclos disease, inflammatory breast cancer, Wilms tumor, Ewing sarcoma, rhabdomyosarcoma, ependymoma, medulloblastoma, kidney cancer, liver cancer, melanoma, pancreatic cancer, sarcoma, osteosarcoma, giant cell tumor, thyroid cancer acute T-cell leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, hairy cell leukemia, acute lymphoblastic leukemia, acute myeloid leukemia, chronic neutrophilic leukemia, acute lymphoblastic T-cell leukemia, plasmacytoma, immunoblastic leukemic leukemia, immunoblastic multiple cell leukemia megakaryoblastic leukemia, multiple myeloma, acute megakaryocytic leukemia, promyeloleukemia, erythroleukemia, malignant lymphoma, lymphogranulomat oz, non-Hodgkin’s lymphomas, lymphoblastic T-cell lymphoma, Burkitt’s lymphoma, follicular lymphoma, neuroblastoma, bladder cancer, urothelial cancer, vulvar cancer, cervical cancer, endometrial cancer, kidney cancer, mesothelioma, esophageal cancer, salivary glands, and liver cancer, stomach cancer, nasopharyngeal cancer, buccal cancer, oral cancer, gastrointestinal cancer, and testicular cancer.

12. The method according to p. 10 and 11, where the cancer is prostate cancer.

13. The method according to p. 10 and 11, where the cancer is FTEN-deficient cancer.

14. The method according to any one of p. 10-13, where the compound (I) is present in the form of an acetate ester and the compound (II) is in the form of a hydrochloride.

15. A method of treating cancer in a person in need thereof, which comprises administering a therapeutically effective amount of a combination of (3β) -17 (pyridin-3-yl) androsta-5.16-dien-3-ol or a pharmaceutically acceptable salt or ester thereof, and N - {(1S) -2-amino-1 - [(3-fluorophenyl) methyl] ethyl} -5-chloro-4- (4-chloro-1-methyl-1H-pyrazol-5-yl) -2- thiophenecarboxamide or a pharmaceutically acceptable salt thereof, to a person in need thereof, where the combination is administered at a specific time and where the combination is administered at a time.

16. The method of claim 15, wherein (3β) -17 (pyridin-3-yl) androsta-5.16-dien-3-ol is present in the form of an acetate ester.

17. The method according to p. 15, where N - {(1S) -2-amino-1 - [(3-fluorophenyl) methyl] ethyl} -5-chloro-4- (4-chloro-1-methyl-1H- pyrazol-5-yl) -2-thiophenecarboxamide is present in the form of a hydrochloride.

18. The combination according to claim 1 or claim 2, or the combination kit according to claim 5, wherein the amount of a compound of structure (I) is an amount selected from 750 mg to 1250 mg, and this amount is suitable for administration once a day in one or more tablets, and the amount of a compound of structure (II) is the amount selected

from 50 mg to 300 mg, and this amount is suitable for administration once a day.

19. The use of a combination according to claim 1 or 2 or a combination kit according to claim 5 for the manufacture of a medicament or medicaments for the treatment of cancer.

20. A combination or combination kit for use in the treatment of cancer, comprising a therapeutically effective amount of a combination of (3β) -17 (pyridin-3-yl) androsta-5,16-dien-3-ol or a pharmaceutically acceptable salt or ester thereof and N- {(1S) -2-amino-1 - [(3-fluorophenyl) methyl] ethyl} -5-chloro-4- (4-chloro-1-methyl-1H-pyrazol-5-yl) -2-thiophenecarboxamide or its pharmaceutically acceptable salt,

where the combination is administered at a specific period, and

where the combination is administered over a period of time.